The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI

A Randomized Controlled Study on the Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI

The purpose of this study was to evaluate the efficacy and safety of ketotifen (MC stabilizer) on the basis of standard treatment after primary PCI in STEMI patients. The ketotifen group and the control group were the ketotifen group and the control group. The control group continued to receive STEMI standard treatment. The ketotifen group received ketotifen for 3 months on the basis of standard treatment within 24 hours after primary PCI, and was followed up for 1 year. Infarct size, as well as differences in echocardiography, markers of two-dimensional speckle tracking, inflammatory factors and MC markers, and major adverse cardiovascular events.

Study Overview

• Status: Not yet recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: Ketotifen Fumarate; Drug: standard treatment

Detailed Description

Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute ST-segment elevation myocardial infarction (STEMI). However, STEMI after PCI may still have ischemia-reperfusion injury, inappropriate ventricular remodeling and myocardial fibrosis, which may be related to the inflammatory response of STEMI. Mast cells (MCs) and their degranulation products play an important role in the inflammatory response as well as inducing a series of inflammatory factors. It has been observed in animal experiments that MC stabilizers can improve the ejection fraction, reduce myocardial infarction size and myocardial fibrosis in patients with STEMI, but there is a lack of clinical studies to confirm the role of MC stabilizers in STEMI. The purpose of this study was to evaluate the efficacy and safety of ketotifen (MC stabilizer) on the basis of standard treatment after primary PCI in STEMI patients. The ketotifen group and the control group were the ketotifen group and the control group. The control group continued to receive STEMI standard treatment. The ketotifen group received ketotifen for 3 months on the basis of standard treatment within 24 hours after primary PCI, and was followed up for 1 year. Infarct size, as well as differences in echocardiography, markers of two-dimensional speckle tracking, inflammatory factors and MC markers, and major adverse cardiovascular events, to demonstrate that ketotifen can reduce ischemia-reperfusion injury and improve ventricular reperfusion in AMI. It provides new ideas for the treatment of AMI and a new basis for the optimization of STEMI treatment strategies.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ming Cui, Doctor; Phone Number: +8615611908487; Email: mingcui@bjmu.edu.cn
• Study Contact Backup: Name: Penguin Xie, master; Phone Number: +8618810793282; Email: xiepengxin2014@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages above 18 and below 80, gender is not limited;
• Meet the diagnostic criteria for STEMI (diagnostic criteria: ischemic chest pain lasting ≥30 min; ST segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevation of myocardial markers) , have completed primary PCI, and received standard treatment according to the Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2019)", including dual antiplatelet, anticoagulation, beta receptor Blockers, statins, etc.
• No contraindications to ketotifen;
• Agree and cooperate with participating in this research.

Exclusion Criteria:

• Severe heart failure, such as Killip grade III-IV or LVEF <35%;
• Coronary artery bypass grafting within the past 3 years or planned;
• The patient is using or planning to use long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
• Patients with severe liver and kidney disease;
• Patients with a history of cancer or lymphoproliferative diseases in the past 3 years;
• Implanted metal in the body or claustrophobia cannot accept cardiac MRI;
• Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ketotifen; Ketotifen was added to the standard treatment within 24 hours after the completion of primary PCI for 3 months, taking 1 mg each time, 1-2 times a day according to the patient's tolerance.	Drug: Ketotifen Fumarate; Ketotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance; Other Names: Ketotifen
Sham Comparator: Control group; Standard treatment according to guidelines	Drug: standard treatment; Standard treatment methods will be determined according to the Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2019) [19], including primary PCI, dual antiplatelet, anticoagulation, ACEI/ARB/ARNI, β-receptor blockade drugs, statins, etc.; Other Names: standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarct size	Myocardial infarct size was assessed by cardiac MRI	3 months after myocardial infarction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular systolic function	Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm	24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Left ventricular ultrasound strain	Two-dimensional speckle tracking imaging measures the movement in the long-axis direction as the overall longitudinal strain, the movement in the short-axis direction as the overall radial strain, reflecting the degree of wall systolic thickening, and the annular motion in the short-axis direction as the overall circumferential strain	24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory factors and MC markers	Analysis of inflammatory factors (such as TNF-α, IL1, IL6, etc.) and MC markers (chymotrypsin)	24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events	MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)	12 months
Drug-Related Adverse Reactions	Fatigue, lethargy and lethargy, nausea and other gastrointestinal adverse reactions	12 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Ming Cui, Doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: STEMI; prognosis; ketotifen; mast cell
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Ketotifen
• Other Study ID Numbers: M2022319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No